The present disclosure relates to infusion therapy with antimicrobial vascular access devices. Infusion therapy is one of the most common health care procedures. Hospitalized, home care, and other patients receive fluids, pharmaceuticals and blood products via a vascular access device inserted into the vascular system. Infusion therapy may be used to treat an infection, provide anesthesia or analgesia, provide nutritional support, treat cancerous growths, maintain blood pressure and heart rhythm, or many other clinically significant uses.
Infusion therapy is facilitated by a vascular access device. The vascular access device may access a patient's peripheral or central vasculature. The vascular access device may be indwelling for short term (days), moderate term (weeks), or long term (months to years). The vascular access device may be used for continuous infusion therapy or for intermittent therapy.
A common vascular access device is a plastic catheter that is inserted into a patient's vein. The catheter length may vary from a few centimeters for peripheral access to many centimeters for central access. The catheter may be inserted transcutaneously or may be surgically implanted beneath the patient's skin. The catheter, or any other vascular access device attached thereto, may have a single lumen or multiple lumens for infusion of many fluids simultaneously.
The proximal end of the vascular access device commonly includes a Luer adapter to which other medical devices may be attached. For example, an administration set may be attached to a vascular access device at one end and an intravenous (IV) bag at the other. The administration set is a fluid conduit for the continuous infusion of fluids and pharmaceuticals. Commonly, an IV access device is a vascular access device that may be attached to another vascular access device, closes or seals the vascular access device, and allows for intermittent infusion or injection of fluids and pharmaceuticals. An IV access device may include a housing and a septum for closing the system. The septum may be opened with a blunt cannula or a male Luer of a medical device.
Complications associated with infusion therapy may cause significant morbidity and even mortality. One significant complication is catheter related blood stream infection (CRBSI). An estimate of 250,000-400,000 cases of central venous catheter (CVC) associated BSIs occur annually in US hospitals. Attributable mortality is an estimated 12%-25% for each infection and a cost to the health care system of $25,000-$56,000 per episode.
Vascular access device infection resulting in CRBSIs may be caused by failure to regularly clean the device, a non-sterile insertion technique, or by pathogens entering the fluid flow path through either end of the path subsequent to catheter insertion. Studies have shown the risk of CRBSI increases with catheter indwelling periods. Thus, when a contaminated vascular access device or infusate is used in an infusion procedure, pathogens are allowed to enter the patient's bloodstream and cause a BSI.
The germicidal or biocidal effects of ultra violet (UV) radiation have been known since the late 19th century and in recent years the use of UV radiation has gained broad acceptance in the fields of water and air purification and has found some limited use in food processing and medical device sterilization.
UV light consists of high energy photons which occupy the 200 to 400 nanometer wavelengths of the electromagnetic spectrum. This means that UV light emits slightly less energy than soft X-ray radiation, but significantly more than visible light. UV energy does not directly kill pathogens, but rather causes a photochemical reaction with the genetic structure which inhibits the ability of the pathogens to reproduce, therefore, in effect, killing the pathogen.
The amount of energy delivered by UV light is inversely proportional to its wavelength, therefore, the shorter the wavelength, the greater the energy produced. In general, the UV light portion of the spectrum is made up of three segments: UV-A (315-400 nm), used for sun-tanning lamps; UV-B (280-315 nm); and UV-C (200-280 nm). The UV-B and UV-C regions contain wavelengths with the best biocidal action. Studies have shown that the wavelengths most effective in killing microbes are between 250-265 nm.
When using UV-C radiation to sterilize medical devices, precautions must be taken to prevent the patient and/or physician from being exposed to the harmful UV-C radiation. Some biocidal systems and methods require the use of external covering or shields to provide adequate protection. Other systems use lower intensity biocidal lamps. However, these systems fail to provide convenient and efficient sterilization, thereby requiring that additional steps be taken to ensure complete and safe antiseptic conditions.
Thus, what are needed are systems, devices, and methods to prohibit, limit, or otherwise eliminate vascular access device and infusate contamination to reduce the risk and occurrence of CRBSIs in a safe and efficient manner. The various embodiments of the present invention meet this need.